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Schering Corporation, et al v. Mylan Pharmaceuticals

May 17, 2011


The opinion of the court was delivered by: Linares, District Judge.



This matter comes before the Court by way of a motion for partial summary judgment filed by Plaintiffs, Schering Corporation and MSP Singapore Company LLC (collectively, "Schering"), on March 11, 2011, seeking dismissal of Defendant Mylan Pharmaceuticals, Inc.'s ("Mylan") Fifth Separate Defense and Fourth Counterclaim. The Court has considered the parties' submissions in support of and in opposition to the present motion and decides the matter without oral argument pursuant to Rule 78 of the Federal Rules of Civil Procedure. For the reasons set forth below, Schering's motion is granted.


The following facts are undisputed, except where noted. On December 16, 2009, Schering filed a Complaint alleging that Mylan's filing of an Abbreviated New Drug Application infringed two of Schering's patents, specifically United States Patent Nos. RE37,721 ("the '721 patent") and 5,846,966 ("the '966 patent") (collectively, the "patents-in-suit"). (Schering's Local Civ. R. 56.1 Stmt. of Uncontested Facts in Support of Their Mot. for Summ. J. ["SOF"] ¶¶ 3--6.) On March 2010, Mylan filed an Amended Answer, asserting as its Fifth Separate Defense and Fourth Counterclaim that the patents-in-suit are unenforceable for inequitable conduct by Schering during patent term extension proceedings. (SOF ¶ 8.) Mylan specifically alleges that during the pendency of the patent term extension application for the '721 patent, Schering violated the disclosure obligations set forth by the United States Patent and Trademark Office ("PTO") and thereby committed fraud on the agency. (Am. Answer at 50.) The facts underlying these allegations began a number of years before said application was filed.

On February 4, 1993, Schering disclosed a compound called SCH48461 in Example 9 of International Published Patent Application WO 93/02048 ("the '048 PCT"). (Mylan's Stmt. of Add'l Facts ¶ 1.) Mylan asserts that "[f]ollowing ingestion by a mammal, natural metabolism of SCH48461 by the body results in the formation of compounds encompassed by at least claims 1, 2, 5, and 7 of the '721 patent."*fn1 (Id. at ¶ 2.) In September of 1993, Schering filed a patent application with the PTO that ultimately led to the issuance of the '721 patent. (SOF ¶ 3.) Specifically, an initial patent, United States Patent No. 5,757,115 ("the '115 patent"), issued on June 16, 1998, and that patent was reissued on May 28, 2002 as the '721 patent. (Id.) On December 17, 2002, Schering filed an application for extension of the term of the '721 patent pursuant to 35 U.S.C. § 156 and 37 C.F.R. §§ 1.170--1.791. (Id. at 11.) In 2006, the PTO granted the patent term extension. (Id. at 12--13.)

On June 9, 2010, Schering filed a reissue application for the '721 patent. (Mylan's Stmt. of Add'l Facts ¶ 16.) As part of its declarations accompanying the reissue application, Schering stated that "at least Claim 1 of [the '721 patent] is potentially inherently anticipated by the International published application [of the '048 PCT]." (Id. at ¶ 17.) Schering informed the PTO that because of the "potential invalidity of claims 1, 2, 5, and 7 of both the '721 reissue patent and the '115 patent, in the present reissue application, applicants have amended and narrowed the claims of the '721 reissue patent to exclude compounds 4A, 4B, 4E and 4F, as well as any other putative metabolites of the Example 9 compound (and any other of the exemplified compounds) of the '048 PCT publication." (Id. at ¶ 19.)


A court shall grant summary judgment under Rule 56(c) of the Federal Rules of Civil Procedure "if the pleadings, the discovery and disclosure materials on file, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c).

On a summary judgment motion, the moving party must show, first, that no genuine issue of material fact exists. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). The burden then shifts to the non-moving party to present evidence that a genuine issue of material fact compels a trial. Id. at 324. In so presenting, the non-moving party must offer specific facts that establish a genuine issue of material fact,not just "some metaphysical doubt as to the material facts." Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 586--87 (1986). Thus, the non-moving party may not rest upon the mere allegations or denials in its pleadings. See Celotex, 477 U.S. at 324. Further, the non-moving party cannot rely on unsupported assertions, bare allegations, or speculation to defeat summary judgment. See Ridgewood Bd. of Educ. v. N.E. ex rel. M.E., 172 F.3d 238, 252 (3d Cir. 1999). The Court must, however, consider all facts and their reasonable inferences in the light most favorable to the non-moving party. See Pennsylvania Coal Ass'n v. Babbitt, 63 F.3d 231, 236 (3d Cir. 1995).


Mylan alleges that during the pendency of the '721 patent term extension proceedings, "one or more of the named inventors of the '721 patent knew that certain metabolites which formed in vivo after administration of prior art compound SCH48461 fell within the scope of at least Claims 1, 2, 5, and 7 of the '721 patent" (Mylan's Stmt. of Add'l Facts ¶ 3), and that Schering's failure to disclose such information constituted inequitable conduct before the PTO, rendering the subject patent, and related patents, unenforceable. Schering responds that even if the inventors or Schering's attorneys had such knowledge, a fact which Schering disputes,*fn2 Schering had no duty to disclose such information in connection with those proceedings.

Under the Drug Price Competition and Patent Term Restoration Act of 1984 (the "Hatch-Waxman Act"), a patentee can obtain an extension of the ordinary patent term if the patent claims an invention which is subject to a regulatory review period before its commercial marketing or use. 35 U.S.C. § 156. The Hatch-Waxman Act "has two general purposes: (1) to increase the availability of low-cost drugs by expanding a generic drug approval procedure; and

(2) to further encourage new drug research by restoring some of the patent term lost while drug products undergo testing and await FDA pre-market approval." Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392, 396 (Fed Cir. 1990). A patentee is ...

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